Trial for Safety and Immunogenicity of a Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults

Exclusion Criteria

• •A subject will be excluded if one or more of the following conditions apply:
• •Women Specific:
• •Planning to become pregnant during the 16 weeks after enrollment in the study
• •Subject has received any of the following substances:
• •Systemic immunosuppressive medications within 2 weeks prior to enrollment
• •Blood products within 16 weeks prior to enrollment
• •Immunoglobulin within 8 weeks prior to enrollment
• •Prior vaccinations with an investigational CHIKV vaccine
• •Investigational research agents within 4 weeks prior to enrollment
• •Any vaccination within 2 weeks prior to enrollment
• •Current anti-tuberculosis (TB) prophylaxis or therapy
• •Subject has a history of any of the following clinically significant conditions:
• •A history of immune-mediated or clinically significant arthritis
• •Serious reactions to vaccines that preclude receipt of study injections as determined by the investigator
• •Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
• •Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids
• •Diabetes mellitus (type I or II), with the exception of gestational diabetes
• •Idiopathic urticaria within the past year
• •Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular (IM) injections or blood draws
• •Malignancy that is active or history of a malignancy that is likely to recur during the period of the study
• •Seizure in the past 3 years or treatment for a seizure disorder within the last 3 years
• •Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
• •Psychiatric condition that may preclude compliance with the protocol; past or present psychoses; or a history of suicide plan or attempt within the five years prior to enrollment
• •Any medical or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent